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Chapter 10
NCT02225392). BT procedures were performed by 2 experienced bronchoscopists (P.I.B. and
J.T.A.) in the endoscopy intervention suite at the Department of Pulmonology, Academic
Medical Centre (AMC), Amsterdam, the Netherlands.
Patients
Patients with severe asthma aged between 22 and 61 years, participating in the TASMA trial,
were included in the study. Severe asthma was defined as asthma that was symptomatic
despite treatment with high-dose inhaled corticosteroids (dosage ≥ 500 μg fluticasone or
equivalent per day) and inhaled long-acting β
2
-agonists (dosage of ≥ 100 μg salmeterol or
equivalent per day) with a bronchial hyperresponsiveness tomethacholine (PC
20
< 4mg/ml),
and that fulfilled the World Health Organization or modified Innovative Medicines Initiative
criteria of severe refractory asthma.
15,16
Screening included a spiral computed tomography
scan of the chest and a flexible bronchoscopy to exclude airway abnormalities including
tracheomalacia. Exclusion criteria were a forced expiratory volume in 1s percentage
predicted < 50%, a body mass index > 35, and known allergy to bronchodilators, propofol,
remifentanil, or other sedative medicine.
Sedation intervention
In the AMC Amsterdam (as well as in other hospitals in the Netherlands), endoscopic
procedures are supported by specialised sedation anaesthesia nurses, who perform self-
reliant procedural sedations. They have followed a theoretical and practical sedation
education programof 1 year that is completed by an examination that results in certification.
These specialised sedation anaesthesia nurses provided the sedation with propofol and
remifentanil and were responsible for continuous monitoring during the BT procedure in
the endoscopy suite with an anaesthesiologist on call in case of unexpected events.
Before the beginning of the BT procedure, a peripheral intravenous line was inserted,
and glycopyrrolate 0.2 mg, lidocaine 20 mg, and midazolam 1 mg were administered.
Sedation was started using a remifentanil TCI system (remifentanil [Ultiva] 2 mg powder,
GlaxoSmithKline BV, Philadelphia, PA, USA) starting with a targeted plasma level of 1.5
μg/ml combined with a propofol TCI system (propofol 1%, MCT/LCT Fresenius, Zeist, the
Netherlands) with a targetedplasma level of 1.2 μg/ml. TCImeans aweight- and age-adapted
pre-programmed system using a defined pharmacokinetic model to attain a specific blood
target level. Enough time needs to be taken to achieve the adequate sedation level. Before
introducing the bronchoscope, the level of sedation was assessed using the Observer’s
Assessment of Alertness/Sedation (OAA/S) score. When a score of 3 was reached, meaning
that the patient responded only after his/her name was called loudly or repeatedly, the
bronchoscope was introduced,
17
and additionally lidocaine 1 mg/kg was administered